K110729 · Fujifilm Medical Systems U.S.A, Inc. · MUE · Sep 1, 2011 · Radiology
Device Facts
Record ID
K110729
Device Name
ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM
Applicant
Fujifilm Medical Systems U.S.A, Inc.
Product Code
MUE · Radiology
Decision Date
Sep 1, 2011
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.1715
Device Class
Class 2
Indications for Use
The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
Device Story
Aspire HD (FDR MS-1000) is an integrated full-field digital mammography (FFDM) system. It utilizes a Siemens-manufactured X-ray stand, tube, and generator combined with Fujifilm's amorphous selenium (a-Se) detector and Acquisition Workstation (AWS). The system captures X-ray energy via the a-Se detector, which employs a dual-layer scintillator and direct optical switching circuitry. The AWS, running on Windows Vista or 7, processes image data for technologist preview, quality control, and transmission to printers, diagnostic workstations, or archiving systems. Operated by technologists in clinical settings, the system features automated compression and one automatic exposure control (AEC) mode. The AWS interface allows patient information input, exposure selection, and study management. By providing high-quality digital images, the device assists radiologists in breast cancer screening and diagnosis, offering a digital alternative to traditional screen-film mammography.
Clinical Evidence
Bench testing only. Clinical image attribute review conducted by independent mammographic radiologists in accordance with FFDM 510(k) guidance. Six image sets of screening and diagnostic cases were evaluated to confirm that the Aspire HD provides sufficiently acceptable quality for mammographic use.
Technological Characteristics
System components: Siemens X-ray stand/tube/generator; Fujifilm amorphous selenium (a-Se) detector with dual-layer scintillator and direct optical switching. Connectivity: Networked transmission to printers/workstations/PACS. Software: FDR 1000AWS running on Windows Vista/7. Features: Automated compression, one AEC mode. Imaging metrics: MTF, Noise Analysis, DQE. Regulatory class: II (21 CFR 892.1715).
Indications for Use
Indicated for screening and diagnosis of breast cancer in patients requiring mammographic imaging, consistent with clinical applications of traditional screen-film mammography systems.
Regulatory Classification
Identification
A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”*See* § 892.1(e) for the availability of this guidance document.
{0}------------------------------------------------
419 WEST AVENUE STAMFORD, CT 06902 203-324-2000 PHONE: TOLL-FREE: 800-431-1850 203-353-0926 FAX:
KI10729
#### 510(k) Summary
March 10, 2011 Date Prepared:
#### Submitter's Information
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902 Telephone: (203) 602-3576 Facsimile: (203) 353-0296 Contact: Peter Altman
#### Device Name and Classification:
| Product Name: | Aspire HD Full-Field Digital Mammography X-ray System |
|-----------------------|-------------------------------------------------------|
| Model Number: | FDR MS-1000 |
| Classification Name: | Full-Field Digital Mammography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR 892.1715 |
| Device Class: | Class II |
| Product Code: | MUE |
#### Substantial Equivalence/Predicate Devices:
Siemens Mammomat Novation (P030010)
Siemens Inspiration (P030010/S006)
Although the wording changes slightly from device to device, the Aspire HD and the Siemens Mammomat Novation on both have the same basic Indication For Use (IFU). The IFU for the Siemens Mammomat Inspiration is not publically available, although it is expected to be very similar to the Novation and the Aspire HD. All three devices generate digital mammographic images that are intended for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
All systems employ digital amorphous selenium x-ray detectors integrated into gantry (stand) based x-ray systems. The x-ray stand, tube and generator of the Aspire HD and Inspiration are identical. Note that the Aspire HD's X-ray system is manufactured by Siemens and is the same as that used in the recently approved (November 5, 2010) Siemens Mammomat Inspiration (P030010/S006). The Inspiration is Siemens' successor to the Mammomat Novation 148 (P030010). The technological characteristics of the device are similar as demonstrated by the comparison of imaging characteristics such as MTF, Noise Analysis, DQE, and phantom testing.
A clinical image attribute review was conducted by independent mammographic radiologists in accordance with the FFDM 510(k) Guidance document. The mammographic attributes of six (6) image sets of screening and diagnostic cases were reviewed concluding that the Aspire HD provides sufficiently acceptable quality for mammographic use.
page lotz
Page 25 of 1560
{1}------------------------------------------------
# FUJ!FILM
#### FUJIFILM MEDICAL SYSTEMS USA, INC.
419 WEST AVENUE STAMFORD, CT 06902 203-324-2000 800-431-1850 203-353-0926
#### Description of the Device:
The Aspire HD is an integrated FFDM system combining an X-ray system made by Siemens with Fujifilm's a-Se detector and Acquisition Workstation (AWS). The Aspire HD creates digital mammography images by direct capture of x-ray energy using the a-Se detector is a Fujifilm design utilizing an exclusive dual layer a-Se scintillator with Direct Optical switching circuitry to acquire image data and transfer images to the AWS for automated post processing, technologist preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The Aspire HD provides automated compression and one AEC mode.
The Aspire HD Acquisition Workstation (FDR 1000AWS) includes an off the shelf personal computer, the application software, either Microsoft Vista or Windows 7 Operating System, a Smegapixel portrait type monitor, and a hub. The hub transmits signals between the personal computer and control cabinet, and between the personal computer and exposure stand.
The AWS display primarily consists of three windows:
- Patient Information Input window .
- Exposure Menu Selection window t
- . Study window.
The user may switch between these windows depending on the operation being performed. The X-ray control panel, which controls and observes the exposure stand, is always displayed in the lower part of each window. This allows setting the exposure conditions and confirming the radiation conditions on a single view.
#### Intended Use:
The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
### Safety Information:
The Aspire HD introduces no new safety or efficacy issues other than those already identified with the predicate devices. The results of the Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of moderate concern as per the May 11. 2005 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." and is consistent with the level of concern indicated in the "Class II Special Controls Guidance Document: Full-Field Digital Mammography System" document issued on: November 5, 2010.
#### Conclusion:
This 510/k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate devices.
page 2 of 2
Page 26 of 1560
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol appears to be a stylized representation of a human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Peter Altman Regulatory Consultant FUJIFILM Medical Systems USA. Inc. 419 West Avenue STAMFORD CT 06902
SEP - 1 2011
K110729 Trade Name: Aspire HD (FDR MS-1000) Regulation Number: 21 CFR § 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: June 22, 2011 Received: June 23, 2011
Dear Mr. Altman:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
{3}------------------------------------------------
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S. Postel
Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
## Indications for Use
510(k) Number (if known): _ K (10729
Device Name: Aspire HD (FDR MS-1000)
Indications for Use:
The Fujifilm Digital Mammography System, Aspire HD (FDR MS-1000), generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mary S Postel
(Division Sign-Off)
Radiolonio Office of In vial Diagnostic Device Evaluation and Safety
510K K110729
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
